A New Label for Mifepristone

Abstract

eliminating the requirement that the dose of misoprostol be given in a medical facility, including a protracted stay for observation. The pills are quite expensive because of the manufacturing cost, the overhead associated with administering the care providers' applicationforuse program, and the cost of meeting secure shipping and storage requirements. The changes included in the new label should substantially improve access to medical terminations of pregnancy, not only by reducing the cost of the medication, but also by formally eliminating the requirement for a clinic visit for misoprostol administration and expanding the gestational age range for which the treatment is indicated. Although these label changes may be dismissed as trivial — as the FDA merely catching up with common practice — doing so would underestimate their importance. Several states have passed laws or written regulations to mandate compliance with the more expensive, burdensome, and restrictive requirements of the older labeling. Passage of those targeted regulations has been justified as necessary to protect the health and safety of women seeking these services. The new mifepristone label will strip away that fig leaf, and failure to adopt the new, less restrictive label in laws and regulations will expose the more restrictive regulations for their true intent. Comparison of two doses of mifepristone in combination with misoprostol for early medical abortion: a randomised trial. BJOG 2000; 107: 52430. 3. World Health Organization Task Force on Postovulatory Methods of Fertility Regulation. Medical abortion at 57 to 63 days' gestation with a lower dose of mifepristone and gemeprost: a randomized controlled trial. Acta Obstet Gynecol Scand 2001; 80: 44751. 4. Winikoff B, Dzuba IG, Chong E, et al. Extending outpatient medical abortion services through 70 days of gestational age. Obstet Gynecol 2012; 120: 10706. 5. Goldstone P, Michelson J, Williamson E. Early medical abortion using lowdose mifepristone followed by buccal misoprostol: a large Australian observational study. Med J Aust 2012; 197: 2826.